>> I would like to see NKTR to increase NKTR-214 dose to produce ORR in melanoma and RCC as monotherapy consistent with high dose IL-2, see how far off the current dose level is.
Major development in the past week, both BMY and NKTR have acknowledged higher dose of NKTR-214 might be needed to improve efficacy, and intend to do more dose escalation and optimization I thought they should’ve done long time ago but wouldn’t do.
Main argument left from NKTR recently has been increase of CRs in melanoma over longer treatment period vs what they had argued on multiple fronts previously. I looked at past PIVOT-02 data presentations again, this increase of CRs over time has been seen only in melanoma as far as I can tell, not shown in UC yet, NSCLC fizzled completely, and surprisingly no update from RCC since ASCO2018! And not surprisingly new dose escalation/optimization/combination come from NSCLC and RCC.
Here is my tracking sheet - table does not come out formatted correctly here unfortunately (ASCO2018 had 2 columns for Melanoma and RCC respectively where * from dose escalation and ** from RP2D, 1 column for NSCLC from dose escalation and 1 for UC from RP2D; no UC from SITC2017; no melanoma at ASCO-GI2019 only UC) - will see how RCC and UC CRs change over longer time when future data are presented:
NKTR CRs from PIVOT-02 Efficacy Evaluable Patient Population Only - Nivolumab + NKTR-214
SITC2017* ASCO2018 SITC2018** ASCO-GI2019** ASCO2019** SITC2019**
Melanoma 2/11 3/11* 3/28** 9/38 13/38 13/38
RCC 1/13 1/14* 0/26**
NSCLC 1/5 2/5*
UC 2/10** 5/29
*from dose escalation
**only at RP2D from dose escalation and expansion
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